Annual Report 2015–2016

Target 2: Improve processes for clinical trials
Corporate Plan
Continue to:
• develop and launch an improved ethics application form
• conduct pilot studies to collect data on a good practice research
governance process for clinical trials
• develop a market driven approach to demonstrate quality, safety,
transparency and efficiency of clinical trials
• work with stakeholders to develop contemporary guidance around
safety monitoring and reporting requirements for clinical trials
• work to develop a fully functional clinical trials web portal.
During 2015–16, the NHMRC continued working to streamline processes for clinical trials by:
Work
ongoing
• developing the ethics application form, with beta-testing ongoing as at 30 June 2016 (the form will be
launched in October 2016)
• completing the first phase of pilot studies to collect data on a good practice research governance
process for clinical trials
• developing the Clinical Trials Ready initiative, which will be supported by an expert advisory committee
• developing a draft revision of the Australian Health Ethics Committee position statement on safety
monitoring and reporting requirements for clinical trials (the revision will be completed by October 2016).
NHMRC also began developing a fully functional clinical trials web portal. On International Clinical Trials
Day (20 May 2016), the Minister for Health announced enhancements to the site, including the addition of
subscription notification functionality.
PART 2 Performance Report
Outcome 5: Expediting clinical trials reforms
In 2015–16, NHMRC has continued to work towards simplified and streamlined ethics review,
research governance approval and clinical trial oversight processes. A number of key achievements have
occurred during this time.
The Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research
Governance for streamlined site assessment and authorisation of clinical trials realised significant success.
Evidence from the piloting of the process in 16 sites has demonstrated that, on average, more than 100
days can be saved in the time taken for clinical trial commencement. While there was a small resource
cost, this time saving can help to make Australia more competitive as a destination in which to conduct
clinical trials.
In order to support streamlined research governance authorisation, NHMRC has also been working to
develop a streamlined ethics application. This form, the human research ethics application (HREA), has been
developed using a contemporary IT platform which generates a bespoke application whose questions are
relevant only to the type of research that is being conducted. The HREA is currently in a beta test phase. It is
anticipated that, following incorporation of comments on the form, it will be launched in October 2016.
NHMRC has also simplified the process for safety monitoring and reporting of clinical trials by developing,
in conjunction with the Therapeutic Goods Administration, revised guidance for reporting on clinical trials that
involve medicines and medical devices. This will be published in October 2016.
Annual Report of the National Health and Medical Research Council 2015–2016
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